Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to False Negative Risk
Remel Inc is recalling Oxoid Legionella BCYE Growth Supplement because it may cause false negative Legionella test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen (Legionella) and a risk of harm (false negatives) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Remel Inc is recalling Oxoid Legionella BCYE Growth Supplement, which is packaged in packs of 10-100ml vials. The product is a growth supplement used for the isolation of Legionella. The recall involves lot number 1374439, which has an expiration date of August 31, 2015.
The recall was initiated because the use of the product could result in inadequate recovery of Legionella pneumophila. This issue could lead to false negative reporting in laboratory tests.
The product was distributed nationwide to Florida. Users of the product should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.
- Manufacturer
- Remel Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot number: 1374439
- Exp: 31 Aug 2015
Distribution
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